Bioequivalence of bicalutamide tablet in healthy volunteers / 国际药学研究杂志

ABSTRACT

Objective: To study the pharmacokinetic characteristics and bioequivalence of bicalutamide tablets n healthy volunteers. Methods: A single oral dose of 50 mg bicalutamide test(domestic) or control(import) tablets was given to 20 healthy volunteers n an open randomized cross-over study. The concentrations of bicalutamide were determined with HPLC. The pharmacokinetic parameters were calculated with 3P97 and the bioequivalent test was performed with SAS. Results: The main pharmacokinetic parameters of the test and control drug were as follows Cmax, 691. 50 vs 697. 30 μg/L; Tmax, 20.65 vs 24. 10 h; AUC0-∞, 148 124 vs 153 782 μg · h/L; t 1/2, 127. 46 vs 131. 06 h,respectively. The relative bioavailability was 99. 43%. Conclusion: The test bicalutamide tablet is bioequivalent to the control formulation.